A Randomized Trial of Aprotinin-Free Fibrin Sealant Versus Absorbable Hemostat

Abstract

Background: This study evaluated the safety and hemostatic effectiveness of a tranexamic acid-and aprotinin-free fibrin sealant versus an absorbable hemostat in soft tissue during elective retroperitoneal or intra-abdominal surgery. Materials and Methods: This randomized, active-controlled, multicenter study enrolled patients who were undergoing elective retroperitoneal or intra-abdominal surgery and required adjunctive hemostatic measures at the target bleeding site (TBS). Patients were randomized (time ¼ 0 minutes) to receive fibrin sealant or absorbable hemostat. The primary endpoint was the absence of bleeding at the TBS at 10 minutes. Secondary endpoints included the absence of bleeding at 4 and 7 minutes and the incidence of treatment failure (bleeding at 10 minutes or brisk bleeding requiring additional hemostatic measures), and the incidence of complications potentially related to bleeding. Adverse events were assessed. Results: Patients (N ¼ 124) were randomized to receive fibrin sealant (n ¼ 62) or absorbable hemostat (n ¼ 62). A higher percentage of patients who received fibrin sealant versus absorbable hemostat achieved hemostasis within 10 minutes (95.2% vs 82.3%; 95% CI, 1.02-1.35) and also at 4 (74.2% vs 54.8%; 95% CI, 1.04-1.80) and 7 (90.3% vs 77.4%; 95% CI, 1.00-1.39) minutes. A lower incidence of treatment failure was observed for patients receiving fibrin sealant. Similar incidences of adverse events and complications potentially related to bleeding were observed. Conclusions: This tranexamic acid-and aprotinin-free fibrin sealant is safe and effective for achieving hemostasis in soft tissue during elective retroperitoneal or intra-abdominal surgery.

A systematic review on the use of topical hemostats in trauma and emergency surgery

“…The two components usually contain added plasmatic proteins such as factor XIII, fibronectin, and an anti-fibrinolytic agent like aprotinin or tranexamic acid [ 7 ]. Nowadays, aprotinin-free and tranexamic acid-free formulations are available [ 3 , 5 ] reducing the risk of side effects, such as aprotinin-associated hypersensitivity reactions, and tranexamic acid-associated neurotoxicity [ 3 , 5 , 20 – 23 ]. Several adhesives are available as liquid formulations (Evicel®, Crosseal™, Quixil®, Floseal®, Surgiflo®, Tisseel®, Beriplast P®) or as medicated sponge/patch (Tachosil®, Evarrest®).…”

“…Craig and coworkers [ 5 ], in a randomized, multicenter, active-controlled study evaluated the efficacy and the effectiveness of liquid fibrin adhesive, in comparison to mechanical hemostats, to control mild to moderate bleeding on 124 patients undergoing retroperitoneal and intraperitoneal procedures at 10 min after randomization. Overall, a higher percentage of patients who received liquid fibrin adhesive achieved hemostasis within 10 min compared with those who received the mechanical hemostat (RR 1.16, 95% CI, 1.02–1.35; p < .05).…”

Fibrin Sealant: The Only Approved Hemostat, Sealant, and Adhesive—a Laboratory and Clinical Perspective

“…These clinical trials included clinically relevant and statistically significant findings in multiple surgical specialties: burn [54], cardiac [51, 57], general [60], pediatric (cannulation for extracorporeal oxygenation {ECHMO}) [52], hepatic [56], orthopedic [37, 40, 41, 53], and vascular surgery [39, 55, 58, 59, 61]. …”

Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft‐Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non‐cardiac) Surgery: A Randomized, Controlled, Superiority Trial

“…The assumed success rate in the control arm (50 %) was based on the results of a previous study [8]. The first efficacy analysis was planned at 90 subjects, with further analysis every 30 subjects.…”